Currently, a number of diseases and disorders are effectively treated and/or managed by administering various pharmacologic agents to the subjects that are suffering from those diseases and disorders. In this regard, and to provide standardized care for these subjects, a number of dosing regimens and guidelines have further been developed in recent years for each of the various pharmacologic agents. However, these dosing regimens and guidelines have often overlooked not only the complexity of the diseases and disorders being treated by the pharmacologic agents, but the dosing regimens and guidelines have also often overlooked the variability in the responses each particular subject may have to a particular pharmacologic agent, which may then lead to an adverse outcome.
For example, anemia in subjects suffering from end-stage renal disease (ESRD) is often effectively treated by the administration of erythropoiesis-stimulating agents (Epo), such as recombinant human erythropoietin, which increase the amount of red blood cells and hemoglobin found in these subjects. To facilitate the effective administration of Epo, the National Kidney Foundation-Kidney/Disease Outcomes Quality Initiative (NKF-K/DOQI) has developed and published guidelines on Epo dosing to achieve a target hemoglobin range (see National Kidney Foundation: NKF-K/DOQI Clinical Practice, Guidelines for Anemia of Chronic Kidney Disease: Update 2000. Am. J. Kidney Dis. 37: S182-S238, 2001). However, despite these guidelines, it is frequently observed that subjects move into, through, and out of the target hemoglobin range over the course of a year of treatment with Epo, and that only approximately one-third (38%) of the subjects are within the target range at any given time (see Lacson E, Ofsthun N, Lazarus J M: Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am. J. Kidney Dis. 41: 111-124, 2003). This behavior is not surprising given the contribution of measurement error, the fact that subjects' responsiveness to Epo can change over time, and the economic and medical pressures to avoid falling below or to avoid exceeding specific levels of hemoglobin. Nevertheless, it has still been found that in subjects with chronic kidney disease, the poor management of hemoglobin levels can lead to an increased risk of adverse events.
Accordingly, a system and method for dosing pharmacologic agents, such as Epo, that allows more precise control over the dosing of the pharmacological agents, while also taking into account the variability among subjects and their responses, would be both highly desirable and beneficial.